Registration & Dossier Management allows users to create and export a Dossier Binder for a specific requirement that includes a list of all expected documents needed for a submission. Vault organizes the documents in nested hierarchical sections that match the Requirement hierarchy structure.
Configuration Overview
Configuring your Vault to use Dossier Binders involves the following steps:
- Enable binder export in your Vault so users can export Dossier Binders
- Set up EDL in your Vault to automatically add expected documents to Dossier Binders
- Optional: Configure Requirement object types
- Configure a document lifecycle for Dossier Binders
- Optional: Configure DAC for documents to define how Vault automatically assigns users to document roles for documents in Dossier Binders
- Configure a document type for generated Dossier Binders
- Configure object actions so users can create and export Dossier Binders
- Configure the Requirement object layout
- Configure user permissions
Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.
Enabling Binder Export
You must enable the binder export feature on the Admin > Settings > General Settings page for users to export Dossier Binders. See Binder Administration for more details.
You can also configure your Vault to export a Dossier Binder with less than 100 documents as a single merged PDF file with the Regulatory Documents application.
Setting up EDL
You must set up EDL in order for Vault to automatically match and add documents to the Dossier Binder sections based on the EDLs in a Requirement hierarchy. When users trigger Dossier Binder creation, Vault adds the documents to the relevant binder section for every EDL Item related to each Requirement.
Configuring Requirement Object Types
You can configure custom object types for the Requirement object. If you do this, you must assign the Binder field to all object types. If you do not assign the field to all object types, the Create Binder and Create and Export Binder actions will fail.
Configuring a Document Lifecycle
When users run the Create Binder and Create and Export Binder actions, Vault applies a specified lifecycle to generated Dossier Binders. Ensure that a document lifecycle is configured, which you will assign to the appropriate document type, and then specify in the Binder Lifecycle field when configuring the actions.
Configuring DAC for Documents
If you want Vault to automatically assign users to specific document roles on documents in generated Dossier Binders, you must configure DAC for documents for the appropriate lifecycle.
Note: Vault does not assign any configured document lifecycle roles to Dossier Binders generated by the Create Binder and Create and Export Binder actions.
Configuring a Document Type
When users run the Create Binder and Create and Export Binder actions, Vault applies a specified document type and lifecycle to generated Dossier Binders. You can specify any childless document type, subtype, or classification in the Binder Type field after completing the following:
- Add the Requirement shared field to the appropriate document type, subtype, or classification. When users trigger Dossier Binder creation, Vault automatically populates this field with the name of the parent record on which they triggered the action.
- Add the applicable lifecycle to the Available Lifecycles field on the General tab of the appropriate document type, subtype, or classification.
Configuring Dossier Binders Object Actions
You can configure the following actions on the Requirement object so users can create and export Dossier Binders with the appropriate sections and documents:
If you configured object types on the Requirement object, assign the actions to all applicable object types. If you add any of these actions as record actions, do not select the Available in All Lifecycle States checkbox.
Configuring the Create Binder Action
The Create Binder action allows users to create a Dossier Binder based on all related Requirement records in the hierarchy, their related EDL Items, and applicable matched documents.
Depending on your business needs, you can:
- Add this action as an entry action on any Requirement lifecycle state.
- Add this action as a user action on any Requirement lifecycle state.
- Add this action as a record action on the Requirement object.
When configuring the action on a specific lifecycle state, you must define the following fields:
- Binder Type: The name of an active document type, subtype, or classification Vault applies to generated Dossier Binders. Do not enter a document type with child subtypes or a subtype with child classifications.
- To reference a subtype or classification, you must include the appropriate hierarchical parents in dot-separated format. For example, to reference the
formulation__csubtype of thedossier__cdocument type, you’d enterdossier__c.formulation__c, and to reference thesafety_data_sheet__cclassification of theformulation__csubtype anddossier__cdocument type, you’d enterdossier__c.formulation__c.safety_data_sheet__c.
- To reference a subtype or classification, you must include the appropriate hierarchical parents in dot-separated format. For example, to reference the
- Binder Lifecycle: The name of an active document lifecycle Vault applies to generated Dossier Binders. The lifecycle must be available for the document type, subtype, or classification you entered in the Binder Type field.
Configuring the Create and Export Binder Action
The Create and Export Binder action allows users to create a Dossier Binder based on all related Requirement records in the hierarchy, their related EDL Items, and applicable matched documents, and then export the Dossier Binder as a ZIP file. The exported Dossier Binder maintains the requirement hierarchy as nested folders in the export. Depending on your business needs, you can:
- Add this action as a user action on any Requirement lifecycle state.
- Add this action as a record action on the Requirement object.
When configuring the action on a specific lifecycle state, you must define the following fields:
- Binder Type: The name of an active document type, subtype, or classification Vault applies to generated Dossier Binders. Do not enter a document type with child subtypes or a subtype with child classifications.
- To reference a subtype or classification, you must include the appropriate hierarchical parents in dot-separated format. For example, to reference the
formulation__csubtype of thedossier__cdocument type, you’d enterdossier__c.formulation__c, and to reference thesafety_data_sheet__cclassification of theformulation__csubtype anddossier__cdocument type, you’d enterdossier__c.formulation__c.safety_data_sheet__c.
- To reference a subtype or classification, you must include the appropriate hierarchical parents in dot-separated format. For example, to reference the
- Binder Lifecycle: The name of an active document lifecycle Vault applies to generated Dossier Binders. The lifecycle must be available for the document type, subtype, or classification you entered in the Binder Type field.
Configuring the Export Binder Action
The Export Binder action allows users to export a previously-created Dossier Binder as a ZIP file, which maintains the requirement hierarchy as nested folders in the export.
Depending on your business needs, you can:
- Add this action as a user action on any Requirement lifecycle state.
- Add this action as a record action on the Requirement object.
Limitations
Vault does not support Binder Types for document types with child subtypes or subtypes with child classifications. If you enter a parent document type or subtype in the Binder Type field when configuring the Create Binder and Create and Export Binder actions on a Requirement lifecycle state, Vault will display an error that the document type does not exist or is not active.
Configuring the Requirement Object Layout
You must add the following fields to the Requirement object layout on all object types:
- Binder: Vault automatically populates this field when it creates a Dossier Binder.
- Dossier Folder: Users can populate this field to determine if the requirement will be a section in the Dossier Binder. You can configure defaults for this field so that users do not have to manually populate this field on all applicable Requirement records.
Configuring User Permissions
You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:
Export Dossier Binders
- For the Requirement object: Read permission on the Binder field.
- Users must have the Security Profile: Application: Document: Download Rendition permission. Without this permission, the exported ZIP file will not include any folders or documents.
- Users must have the View Content and View Document document roles on all documents in a Dossier Binder for those documents to be included in the export. If you configured the Create Binder and Create and Export Binder actions on specific lifecycle states, users must also have these permissions on the applicable lifecycle states.
Related Permissions
You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:
| Type | Permission | Controls |
|---|---|---|
| Security Profile | Admin: Configuration: Document Types: Edit | Ability to modify document types. |
| Security Profile | Admin: Configuration: Document Lifecycles: Edit | Ability to modify document lifecycles. |
| Security Profile | Admin: Configuration: Objects: Create, Edit | Ability to create and modify Vault objects. |
| Security Profile | Admin: Security: Permission Sets: Edit | Ability to modify permission sets for users. |